PMV Pharmaceuticals, Inc. recently shared updates on its clinical trials for PC14586 (rezatapopt) and its financial standing in its Form 10-Q report for the quarter ended September 30, 2024. The company is focused on developing small molecule, tumor-agnostic therapies targeting p53 mutations, with PC14586 as its lead product candidate.
Clinical Trial Updates
The Phase 2 monotherapy portion of the PYNNACLE trial, evaluating PC14586 in patients with locally advanced or metastatic solid tumors harboring a p53 Y220C mutation, is ongoing. Over 75% of the trial sites have been activated globally. Interim data from this registrational portion of the trial is anticipated by mid-2025. The FDA has granted Fast Track Designation to PC14586 for this indication.
However, PMV Pharmaceuticals discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial, which was evaluating rezatapopt in combination with Merck’s anti-PD-1 therapy, pembrolizumab (KEYTRUDA®). The reasons for this discontinuation were not disclosed in the report.
New Collaborations for Combination Therapy
PMV Pharmaceuticals announced collaborations with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study. This study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacytidine in patients harboring a TP53 Y220C mutation. Enrollment is expected to begin in the first quarter of 2025.
Financial Overview and Strategic Initiatives
PMV Pharmaceuticals reported a net loss of $19.2 million for the quarter ended September 30, 2024, an increase of $2.6 million compared to the same period in 2023. Research and development expenses contributed to this increase. However, the net loss for the nine months ended September 30, 2024, decreased by $17.5 million compared to the same period in 2023, totaling $35.7 million.
As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $197.9 million. PMV Pharmaceuticals believes that its current financial resources will be sufficient to fund operations through the end of 2026. The company is focused on advancing its clinical trials, particularly the Phase 2 monotherapy registrational portion of the PYNNACLE trial for PC14586.
In January 2024, PMV Pharmaceuticals implemented a restructuring plan involving a 30% reduction in workforce to streamline operations and preserve capital. The company also terminated its lease for office and laboratory space in Princeton, New Jersey, and signed sublease agreements for new facilities in Princeton and Hopewell, New Jersey.
